Genotype 4 Chronic Hepatitis C Infection Clinical Trial
Official title:
Pilot Study to Determine the Efficacy and Safety of Combining Boceprevir With Peginterferon Alfa-2b and Ribavirin in the Treatment-naive Patients Infected With Genotype 4 Chronic Hepatitis C Infection
Hypothesis Combination of Boceprevir with Ribavirin in treatment-naïve patients with genotype 4 chronic hepatitis C infection will increase the proportion of patients achieving sustained viral response compared to standard treatment alone.
Objectives:
The primary objective of this study is to assess the efficacy and safety of Boceprevir 800 mg
three times per day (TID) orally (PO) (hereafter called Boceprevir) in combination with
peginterferon alfa-2b 1.5 μg/kg once per week (QW) subcutaneously (SC) plus weight-based
dosing (WBD) of ribavirin (800 to 1400 mg/day) compared to standard of care (SOC) (therapy
with peginterferon alfa-2b (PEG)+ribavirin (RBV) WBD) in previously untreated adult subjects
with chronic hepatitis C (CHC) genotype 4 infection.
Primary Trial Objectives:
- The primary efficacy objective of this study is to assess the efficacy of Boceprevir in
combination with PEG 1.5 μg/kg QW SC plus WBD of RBV (800 to 1400 mg/day) compared to the
efficacy of SOC (therapy with PEG+RBV WBD) in the Control Arm in previously untreated adult
subjects with CHC genotype 4 infection
;